K233234

PressON Spinal Fixation System

510(k) number
K233234
Device name
PressON Spinal Fixation System
Applicant
Nexus Spine, LLC UT · US
Product code
NKB — Thoracolumbosacral Pedicle Screw System
Decision date
2023-10-26
Date received
2023-09-28
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K233234.pdf

Official FDA record: K233234
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.